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Table 1 Item tracking matrix summarising the item versions tested in each round of cognitive debriefing and the final items taken forward for psychometric validation

From: Development and content validity testing of patient-reported outcome (PRO) items to assess chest congestion associated with the common cold for use in children and adolescents

Concept

Item tested in round 1

Item tested in round 2

Rationale

Final item

Difficulty breathing

ePRO1. “…how hard was it to breathe air deep into your chest?”

UNCHANGED: ePRO1. “…how hard was it to breathe air deep into your chest?”

Well understood and equally relevant to Paper 1 but has fewer words for children

RETAIN

ePRO1. “…how hard was it to breathe air deep into your chest?”

Paper1. “…how hard was it to breathe air deep into your chest because of your cold?”

UNCHANGED: Paper1. “…how hard was it to breathe air deep into your chest because of your cold?”

ePRO1 performed similarly and has fewer words for children

DELETE

Chest tightness

ePRO2. “…how tight did your chest feel because of your cold?”

UNCHANGED: ePRO2. “…how tight did your chest feel because of your cold?”

Paper2 performed similarly and has fewer words for children

DELETE

Paper2. “…how tight did your chest feel?”

UNCHANGED: Paper2. “…how tight did your chest feel?”

Well understood and equally relevant to Paper1, but has fewer words for children

RETAIN and move to ePRO

ePRO2. “…how tight did your chest feel?”

Chest pain

ePRO3. “…how much has your chest hurt when you’ve coughed?”

UNCHANGED: ePRO3. “…how much has your chest hurt when you’ve coughed?”

Was well understood and relevant to the majority of participants

RETAIN

ePRO3. “…how much has your chest hurt when you’ve coughed?”

Paper3. “…how much has your chest hurt due to being stuffed up?”

UNCHANGED: Paper3. “…how much has your chest hurt due to being stuffed up?”

Poorly understood item across the different age groups

DELETE

Chest feels heavy

ePRO4. “…how heavy did your chest feel?”

UNCHANGED: ePRO4. “…how heavy did your chest feel?”

Both items assessing chest heaviness performed similarly yet ePRO4 followed the same format as the chest tightness item and so it was agreed that children would find this easier to understand

RETAIN

ePRO4. “…how heavy did your chest feel?”

Paper4. “…how much of the time has your chest felt heavy?”

UNCHANGED: Paper4. “…how much of the time has your chest felt heavy?”

ePRO4 was easier for the younger participants to read and understand

DELETE

Chest feels full

ePRO5. “…how much did your chest feel full of mucus (the goo that comes out of your nose)?”

AMENDED WORDING: ePRO5. “…how much did your chest feel full of mucus (goo)?”

Item performed equally well with the term ‘goo’ and ‘goo that comes out of your nose’ and so it was agreed that fewer words would be easier for children to understand

RETAIN WITH WORDING FROM ROUND TWO

ePRO5. “…how much did your chest feel full of mucus (goo)?”

ePRO6. “…how stuffed up did your chest feel?”

UNCHANGED: ePRO6. “…how stuffed up did your chest feel?”

Performed similarly to Paper5a but has fewer words for children

RETAIN

ePRO6. “…how stuffed up did your chest feel?”

Paper5a. “…how much did you feel stuffed up in your chest?”

UNCHANGED: Paper5a. “…how much did you feel stuffed up in your chest?”

ePRO6 was better understood and easier for younger participants to understand

DELETE

Paper5b. “…how much did you feel clogged up in your chest?”

MOVED TO ePRO: ePRO5b. “…how much did you feel clogged up in your chest?”

ePRO5c was better understood and easier to read for the younger participants

DELETE

Paper 5c. “…how clogged up did your chest feel?”

MOVED TO ePRO: ePRO5c. “…how clogged up did your chest feel?”

Performed similarly to Paper 5b but was simpler and shorter for children to read

RETAIN (may require further testing)

ePRO5c. “…how clogged up did your chest feel?”

 

NEW ITEM: ePRO5d. “…how full of stuff did your chest feel?”

Misunderstood by almost a third of participants

DELETE

Paper6c. “…how clear did your chest feel?”

UNCHANGED: Paper6c. “…how clear did your chest feel?”

This was the only item in which the response scale was reversed and so it was agreed that it should be removed to avoid confusion

DELETE

Difficulty clearing mucus

ePRO7. “…how hard was it to clear your chest?”

UNCHANGED: ePRO7. “…how hard was it to clear your chest?”

‘Difficulty clearing mucus’ is a key symptom of chest congestion and so it was agreed that this item should be retained to fully assess this concept

RETAIN (may require upfront question)

ePRO7. “…how hard was it to clear your chest?”

Paper6a. “…how hard was it to clear your throat?”

UNCHANGED: Paper6a. “…how hard was it to clear your throat?”

‘Difficulty clearing mucus’ is a key symptom of chest congestion and so it was agreed that this item should be retained to fully assess this concept

RETAIN and move to ePRO (may require upfront question)

ePRO6a. “…how hard was it to clear your throat?”

Paper6b. “…how hard was it to blow your nose?”

UNCHANGED: Paper6b. “…how hard was it to blow your nose?”

This item was not considered adequately relevant to chest congestion and could be confusing in combination with the added instruction to focus on chest rather than nose

DELETE

Paper8b. “…how hard was it to cough up mucus (goo) from your chest?”

MOVED TO ePRO AND AMENDED WORDING: ePRO8b. “…how hard was it to cough up mucus (gunk) from your chest?”

The term ‘goo’ was better understood and more relevant than the term ‘gunk’

RETAIN WITH ORIGINAL WORDING (may require question upfront)

ePRO8b. “…how hard was it to cough up mucus (goo) from your chest?”

Noise when breathing

ePRO8. “…how much did you wheeze (make a noise) when you breathed?”

ePRO8. “…how much did you wheeze (make a noise) when you breathed?”

Noise when breathing was not a concept of interest and this item had poor relevance

DELETE

Paper7a. “…how much did your chest make a rattling noise when you breathed?”

Paper7a. “…how much did your chest make a rattling noise when you breathed?”

Noise when breathing was not a concept of interest and this item had poor relevance and understanding

DELETE

Paper7b. “…how much have you noticed a sharp noise when you breathed in or out?”

Paper7b. “…how much have you noticed a sharp noise when you breathed in or out?”

Noise when breathing was not a concept of interest and this item had poor relevance and understanding

DELETE